TORONTO – Health Canada says it has approved a plan by GlaxoSmithKline to fix contamination problems it has been experiencing at its Ste. Foy, Que., flu vaccine production plant.
The department says GSK’s action plan and the timelines proposed in it are satisfactory.
Inspections conducted this spring by the U.S. Food and Drug Administration and Health Canada identified problems at the facility largely related to bacterial contamination linked to the plant’s water purification system.
While the precise nature of the problems has not been make public, the FDA issued GSK a warning letter, the last step before possible suspension of a licence to supply to the U.S. market.
And Health Canada’s inspection report identified seven so-called major observations, things classified as signs that production is not consistently hitting required standards.
The company was given a month to respond to the Health Canada report and did so on July 31.
“We have completed the evaluation of GSK’s action plan of its Ste. Foy facility, ID Biomedical. GSK’s proposed approach and the timelines proposed have been deemed acceptable by Health Canada,” the department said Monday via email.
“We will monitor the progress of the implementation of the corrective action plan and conduct regular testing on lots of vaccine prior to their release onto the Canadian market.”
GSK declined to comment about its remediation plan, saying it would be inappropriate to speak publicly about an ongoing process.
The FDA warning letter noted GSK has repeatedly been forced to discard batches of vaccine made at the facility because of bacterial counts that registered above specified limits. The letter, dated June 12, said 21 per cent of this year’s product could not be released to the market.
The plant, which GSK bought from ID Biomedical in late 2005, has contracts to produce 53 per cent of Canada’s seasonal flu vaccine for the coming season as well as 23 million doses for the U.S. market. It is the only flu vaccine production facility located in Canada and holds the country’s long-term pandemic flu vaccine contract.
The FDA has already released for distribution two lots of vaccine from the Ste. Foy plant, GSK says. Flu vaccination programs typically begin in the United States in September, several weeks before the late October or early November launch in most Canadian provinces and territories.
GSK has said in the past that fixing its production problems would not affect its ability to deliver flu vaccine for the Canadian market this fall.